Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure

NCT07366203 | Not Yet Recruiting DMC

• 1 other identifier: NEO-SC3-2025-01
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if a new medical device (SC03 plates) to close the sternum after a sternotomy in patients that have been operated of a cardiac surgery, is safe and effective. The main question it aims to answer is: Do patients that have the sternum closed with the SC03 plates present a stable sternum one month after surgery? Researchers will compare the SC03 plates with stainless steel wires (current standard of care to close the sternum). Participants will:

• be implanted with the SC03 or stainless steel wires.
• visit the clinic one month and six months after surgery
• Keep a diary of their symptoms and analgesia use

Conditions

Sternotomy Closure,Open Heart Surgery

Outcome Measures

Primary Outcomes (1)

• Sternal stability

  Sternal stability measured by clinical assessment using the sternal instability scale (SIS), with grades 0 to 3 where 0 is "Clinically stable sternum" and 3 is "Completely separated sternum - entire length"

  1 month post operatively

Secondary Outcomes (18)

• Safety of the SC03 Plating System

  Perioperative, 1 month and 6 months postoperatively.

• Reinterventions

  1 month and 6 months postoperatively

• Infections

  First month and six months postoperatively.

• Sternal dehiscence

  First month and six months postoperatively

• Sternotomy closure duration

  Surgery

Study Arms (2)

SC03 plates

EXPERIMENTAL

Adjustable carbon fiber sternal plates

Device: SC03 Plating system

Wires

ACTIVE COMPARATOR

Stainless steel sternal wires

Device: Stainless steel wires

Interventions

SC03 Plating system DEVICE

Adjustable carbon fiber sternal plates

SC03 plates

Stainless steel wires DEVICE

Nonabsorbable, sterile, surgical sutures used in sternal closure

Wires

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years old.
• Patient who must undergo surgery in which a median or an upper partial sternotomy is indicated.
• Patients capable of giving their voluntary informed consent to participate in the clinical investigation and from whom written consent has been obtained.
• Patient able and willing to meet the protocol requirements and to follow postoperative care instructions

You may not qualify if:

• Patient with sternal anomalies, such as bone tumours located in the sternum.
• Patient with limited sternum bone blood supply.
• Patient with suspected or known allergies or intolerances to the implants materials: PEEK, carbon fibre, titanium, stainless steel.
• Patient with severe osteoporosis or other degenerative bone diseases that affect the sternum.
• Pregnant or breastfeeding patient or patient planning to become pregnant during the first 6 months after surgery.
• Patient who is currently using opioid analgesics (e.g., morphine, oxycodone, hydrocodone, fentanyl, tramadol) for the management of chronic or acute pain.
• Patient with diagnosis of dementia with a mental status score (MMSE) \< 20.
• Patient with life expectancy lower than 6 months.
• Patient with any other medical process that may compromise or limit the adequate functionality of the implants.
• Patient involved in other interventionist clinical trial or that have been involved in other interventionist clinical trial during the previous 4 weeks.
• Patient with signs of latent or active infection or inflammation on the surgical site.
• Patient with insufficient quantity or quality of sternum bone, or other severe structural bone damage.
• Patient for whom the closure technique cannot ensure sufficient sternal fixation.
• Parasternal sternotomy.
• Patient with intraoperative conditions that may compromise or limit the adequate functionality of the implants or that may prevent the surgeon to use the sternal closure system or that cannot be closed following the product instructions for use

Sponsors & Collaborators

• NEOS Surgery: lead
• Fundacio Privada Mon Clinic Barcelona: collaborator

Central Study Contacts

Laia Rofes, PhD

CONTACT

+34935944726; lrofes@neosurgery.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 26, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share